Tiotropium In Early Chronic Obstructive Pulmonary Disease Patients in China
NCT ID: NCT01455129
Last Updated: 2016-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
841 participants
INTERVENTIONAL
2011-11-30
2016-08-31
Brief Summary
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So far, there is no large-scale clinical trial on long-term intervention with tiotropium bromide (Spiriva) in patients with early stages of COPD (i.e. GOLD Stage I-II COPD or asymptomatic COPD). It would be of great significance for COPD prevention and treatment if the investigators could prove that tiotropium decreases the lung function decline and reverses disease progression in patients with early-stage COPD.
The investigators objective is to evaluate the efficacy of long-term intervention with tiotropium in early stage (FEV1 ≥50% predicted) COPD (difference of trough FEV1, number of exacerbations, time to first exacerbation, quality of life, etc) and relevant pharmacoeconomic endpoints.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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tiotropium group
18 mcg tiotropium, once daily, inhaled by HandiHaler
Tiotropium
18 mcg tiotropium capsule, once daily, inhaled by HandiHaler, for 24 months
placebo group
matching placebo, once daily, inhaled by HandiHaler
placebo
placebo, once daily, inhaled by HandiHaler
Interventions
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Tiotropium
18 mcg tiotropium capsule, once daily, inhaled by HandiHaler, for 24 months
placebo
placebo, once daily, inhaled by HandiHaler
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* GOLD Stage I-II COPD: FEV1/FVC\<70% and FEV1≥50% predicted, measured 20min after 400μg salbutamol inhalation
* With stable COPD: no COPD exacerbation during the latest 4 weeks prior to the recruitment
* With capability of communicating via oral conversation or written documents and signing informed consent
* With agreement to receive and are capable of participating in study related auxiliary examinations
* Capability of proper use of HandiHaler
Exclusion Criteria
* Patients with clinical diagnosis of lung cancer, bronchiectasis, pneumoconioses, or other single restricted ventilation
* Severe cardiovascular, neural, hepatic, renal and hematologic diseases or malignancies that may interfere with the operation of the study
* Patients with prostatic hyperplasia or bladder neck obstruction with significant symptoms, or narrow angle glaucoma
* Patients with known moderate to severe impaired renal function in the opinion of the investigator or creatinine clearance ≤50 ml/min
* Patients with history of asthma, allergic rhinitis, or who have a blood eosinophil count ≥600/mm\^3
* Patients with active pulmonary tuberculosis
* Patients with life-threatening pulmonary embolism, α1-antitrypsin deficiency, or cystic fibrosis
* History of pneumonectomy
* COPD exacerbation in 4 weeks prior to the first visit (V0), or hospitalization and/or antibiotic application and/or oral or intravenous glucocorticosteroids application is required during screening stage.
* Treated with one of the trial drugs during the 30 days or 6 half-lives prior to the first visit (V0), with the selection of the longer period
* Long-term oxygen therapy, frequent use of glucocorticosteroids orally or intravenously at unstable doses(i.e. less than six weeks on stable doses) or at doses in excess of the equivalent of 10 mg of prednisone/day, or long-term use of antibiotics
* Pregnancy, lactation or potential of pregnancy
* Planned hospitalization or blood donation during the trial
* Known hypersensitivity or intolerance to trial drugs
* History of chronic alcohol or drug abuse, or any other conditions that may impact compliance
* Involvement in other clinical studies at the same time
40 Years
85 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Rundo International Pharmaceutical Research & Development Co.,Ltd.
INDUSTRY
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
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Nanshan Zhong
Professor
Principal Investigators
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Nanshan Zhong, Professor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Guangzhou Medical University
Pixin Ran, Professor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Guangzhou Medical University
Locations
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Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
Xinqiao Hospital
Chongqing, Chongqing Municipality, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Liwan Hospital,Guangzhou Medical College
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Guangdong No.2 Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Guangzhou Panyu Center Hospital
Guangzhou, Guangdong, China
Huizhou First Hospital
Huizhou, Guangdong, China
Wengyuan County People's Hospital
Shaoguan, Guangdong, China
The First People's Hospital of Shaoguan
Shaoguan, Guangdong, China
Shaoguan Iron and Steel Group Company limited Hospital
Shaoguan, Guangdong, China
Shenzhen Sixth People's Hospital
Shenzhen, Guangdong, China
The second people's Hospital,Zhanjiang
Zhanjiang, Guangdong, China
Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, China
The Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou, China
Guizhou People's Hospital
Guiyang, Guizhou, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital,Tongji Medical College of HUST
Wuhan, Hubei, China
The Second People's Hospital of Hunan Province
Changsha, Hunan, China
Chenzhou No.1 people's Hopital
Chenzhou, Hunan, China
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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References
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Wu F, Dai C, Zhou Y, Deng Z, Wang Z, Li X, Chen S, Guan W, Zhong N, Ran P. Tiotropium reduces clinically important deterioration in patients with mild-to-moderate chronic obstructive pulmonary disease: A post hoc analysis of the Tie-COPD study. Respir Med. 2024 Feb;222:107527. doi: 10.1016/j.rmed.2024.107527. Epub 2024 Jan 8.
Zhou Y, Zhong NS, Li X, Chen S, Zheng J, Zhao D, Yao W, Zhi R, Wei L, He B, Zhang X, Yang C, Li Y, Li F, Du J, Gui J, Hu B, Bai C, Huang P, Chen G, Xu Y, Wang C, Liang B, Li Y, Hu G, Tan H, Ye X, Ma X, Chen Y, Hu X, Tian J, Zhu X, Shi Z, Du X, Li M, Liu S, Yu R, Zhao J, Ma Q, Xie C, Li X, Chen T, Lin Y, Zeng L, Ye C, Ye W, Luo X, Zeng L, Yu S, Guan WJ, Ran P. Tiotropium in Early-Stage Chronic Obstructive Pulmonary Disease. N Engl J Med. 2017 Sep 7;377(10):923-935. doi: 10.1056/NEJMoa1700228.
Li X, Zhou Y, Chen S, Zheng J, Zhong N, Ran P. Early intervention with tiotropium in Chinese patients with GOLD stages I-II chronic obstructive pulmonary disease (Tie-COPD): study protocol for a multicentre, double-blinded, randomised, controlled trial. BMJ Open. 2014 Feb 18;4(2):e003991. doi: 10.1136/bmjopen-2013-003991.
Other Identifiers
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205.467
Identifier Type: -
Identifier Source: org_study_id
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